BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 17045964 · Received June 2, 2023

    Report

    Report Number
    2955842-2023-15504
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    November 4, 2021
    Report Date
    January 4, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874117306
    PMA / PMN Number
    K191280
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS COULD NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE SYNCHROSEAL INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION, ENGAGEMENT, AND SELF-CHECK TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE JAWS OPENED AND CLOSED PROPERLY. ELECTRICAL CONTINUITY WAS TESTED AND PASSED. VISUAL INSPECTION CONFIRMED ALL NINE JAW CERAMIC DOTS WERE PRESENT AT THE TIPS. THE INSTRUMENT WAS CONNECTED TO THE E-100 GENERATOR AND WAS TESTED FOR ENERGY DELIVERY. THE E-100 GENERATOR DID NOT TURN OFF DURING IN-HOUSE TESTING AND NO INTERMITTENT SEALING WAS OBSERVED. THE GRIP FORCE TEST WAS PERFORMED AND PASSED SPECIFICATION. ADDITIONAL OBSERVATIONS NOT REPORTED BY THE SITE: THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE CUT ELECTRODE LOCATED ON THE BOTTOM JAW OF THE GRIP SET, THE ROOT CAUSE OF WHICH WAS DUE TO A COMPONENT FAILURE. THE INSTRUMENT WAS ALSO FOUND TO HAVE A DISLODGED AND TORN JAW COVER AT THE PROXIMAL END. GOUGE MARKS WERE ALSO OBSERVED. THERE WERE ALSO SCRATCH MARKS ON THE GRIP TIPS. THE ROOT CAUSE OF THESE FAILURES IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE. THE INSTRUMENT WAS FURTHER INVESTIGATED BY AN ISI ADVANCED FAILURE ANALYSIS ENGINEER (AFA). AFA ENGINEER INDICATED THAT THE E-100 GENERATOR SHUT DOWN IS RELATED TO A GENERATOR OVERCURRENT PROTECTION DURING ARCING EVENTS. INSTRUMENT INVESTIGATION RESULTS INDICATED A CUT ELECTRODE THERMAL DAMAGE, LIKELY DUE TO AN ARCING EVENT. MARKINGS ON THE INNER-LOWER JAW SUGGEST THAT THE ARC REMAINED WITHIN THE INSTRUMENT JAWS. THE ISSUE IS INDICATIVE OF A COMPONENT FAILURE. REVIEW OF THE E-100 GENERATOR LOGS IDENTIFIED TWO CUT ELECTRODE SHORTED ERRORS, SUGGESTING THAT ARCING EVENTS OCCURRED, AND SMARTSEAL ANGLE THRESHOLD ERRORS, SUGGESTING THAT SEAL WAS ATTEMPTED WITH TOO MUCH TISSUE BETWEEN THE JAWS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE E-100 GENERATOR CONNECTED TO A SYNCHROSEAL INSTRUMENT POWERED OFF. THE GENERATOR POWERED OFF THEREFORE THERE WAS NO ENERGY DELIVERED. THE USER CONTINUED THE PROCEDURE WITH A BACK-UP INSTRUMENT AND NO FURTHER ISSUES WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33723 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-05 L90210718 0068 10886874117306

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES